As dozens of trial sponsor organizations gear up for COG West Coast’s annual conference in the Bay Area on November 7th-8th, Slope is excited to share that our newly appointed VP of Scientific Operations, Mark Melton, will be giving a keynote presentation on “Best Practices for Optimizing Your Clinical Trial Execution Strategy for Biomarker and PK Samples.”
A leader in clinical research with several years of experience under his belt, Mark has dedicated his career to unifying biomarker scientific designs with the reality of running global trials. His career supporting various sponsor organizations and CROs with biomarker and PK operations has informed his intimate understanding of the challenges with managing complex sampling schemes and the associated data. In engaging with countless trial stakeholders, Mark has formulated a series of best practices that can help sponsors and CROs enhance their study execution strategy for oncology, rare disease, and other therapeutic areas that rely heavily on biomarkers and PK samples.
With one week to go until COG West Coast, here are four questions that Mark’s presentation will address.
Mark will open the discussion with an evaluation of the factors that complicate the management of biomarkers and PK samples. Most notably, as study complexity has become more prolific, there has been an increase in the number of people and organizations who are responsible for analyzing biospecimens and delivering data on a single trial. Precision-based medicine often involves 6 or 7 different labs, each of which are separate entities with different databases and overall capabilities. So how do we get that to work? Slope’s research report with Fierce Biotech dives into some of the other pains felt by study teams as a result of complex study designs (for example, 74% of respondents stated that their research sites do not have the necessary clinical supply they need to enroll and retain patients). Mark will hone in on the implications across the entirety of the biospecimen lifecycle and key areas to consider to help achieve better sample control and data outcomes.
A successful biomarker and PK sample execution strategy hinges on more than just collecting biospecimens and data. It’s also about bridging the gaps between disparate stakeholders who oversee various aspects of the complex web that makes up clinical trial execution.
Mark will discuss the importance of fostering dialogue and exchanging insights that transcend the boundaries that currently exist between research sites, labs, CROs, and sponsors. Each party offers its own set of strengths, weaknesses, and unique perspectives. As an industry we must acknowledge these variations and learn from them.
Understanding the inner workings of each stakeholder involved in biomarker operations and data management is paramount. Mark will discuss how the industry can better adapt and collaborate based on real-world realities.
In the ever-evolving landscape of clinical trials, it’s crucial to understand the intricate network of interdependencies between various processes and stakeholders that manage data inputs and data outputs. Part of that process involves understanding how each data source generates sample data. For example, when looking at various central and specialty labs, what part of their data outputs automatically generate from scanning a barcode on a biospecimen? What part of their data outputs require manual data entry?
Operational efficiency in biomarker or PK operations is tethered to the availability of data. Data transfer agreements may dictate infrequent exchanges, often spanning weeks or months, followed by additional time to make sense of the data. In this world of constant delays, teams specializing in sample operations and data management often turn to unofficial data sources to gain a more real-time perspective.
While official data movement that is governed by agreements and data management plans remains essential, the need for real-time insights cannot be overstated. This complex reality necessitates a new strategy, and Mark will explore this in his presentation.
Clinical trials are a complex, multiplayer game, where businesses, processes, and individual databases converge on the same samples. The data generated by this collaboration becomes the linchpin for trial success. But managing this complexity is akin to a game of telephone — information can get distorted as it passes through various hands. It’s incumbent upon CROs, labs, and sponsors to comprehend this complexity and work together harmoniously, acknowledging their roles and limitations, rather than placing blame. Technology can bring clarity to this intricate dance, and Mark will delve into these solutions.